N/A
Completed N=1,085
Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine
Source: ClinicalTrials.gov NCT01309269 ↗Enrolled (actual)
1,085
Serious AEs
17.6%
Results posted
Oct 2015
Primary outcomePrimary: Hemoglobin Levels at Monthly Intervals — 11.15; 11.31; 11.33; 11.28 g/dL
Summary
This observational study will assess the effect of long-term treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data will be collected from each patient for at least 24 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin Levels at Monthly Intervals |
11.15; 11.31; 11.33; 11.28; 11.28; 11.25 | — |
| PRIMARY Percentage of Participants Within Pre-defined Range of Hemoglobin Values |
37.5; 61.6; 56.0; 80.0; 39.0; 62.2 | — |
| PRIMARY Average Methoxy Polyethylene Glycol-epoetin Beta Dose |
103.23; 102.27; 102.48; 102.64; 104.55; 102.87 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Patients with chronic kidney disease (CKD), stages IV and V
- Treatment with Mircera according to label
Exclusion Criteria
- Pregnant or breastfeeding women
Data sourced from ClinicalTrials.gov (NCT01309269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.